Prescribing spironolactone for acne. Julie C Harper MD

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1 Prescribing spironolactone for acne Julie C Harper MD

2 Conflict of Interest Disclosure none

3 Spironolactone FDA-approval in 1960 Current FDA-approved indications: Primary hyperaldosteronism Edematous conditions for patients with CHF Cirrhosis of the liver Nephrotic syndrome Essential hypertension hypokalemia Spironolactone is not FDA-approved for acne

4 Spironolactone Aldosterone antagonist=> diuresis and lowering of blood pressure Anti-androgen=> improvement in acne and hirsutism Androgen receptor blocker Decreases androgen production Inhibits 5αreductase Increase SHBG

5 Efficacy

6 Spironolactone-efficacy RCT in 21 women showed that spironolactone, 200mg daily, significantly improved acne as assessed by subjective benefit, number of inflamed lesions and by an independently evaluated photographic method Muhlemann et al. Br J Dermatol 1986;115(2): Retrospective chart review of 85 consecutive women treated with spironolactone mg daily either as monotherapy or as an adjunct to standard therapy. 33% cleared 33% marked improvement 27.4% partial improvement 7% no improvement Shaw J. JAAD 2000;43: S

7 Spironolactone Cochrane database review conclusion: There is insufficient data to support efficacy of spironolatone in the treatment of acne. Brown et al. The Cochrane Database of Systematic Reviews. 2009:CD

8 Spironolactone-efficacy 139 Japanese patients with acne (116 females, 23 males) started on 200mg daily of spironolactone 20 weeks of treatment 200mg daily for first 8 weeks After initial 8 weeks, dose lowered by 50mg every 4 weeks 64 females completed the 20 week study Gynecomastia developed in 3 males within 4-8 weeks and subsequently treatment was discontinued in all males Sato et al. Aesth Plast Surg 2006;30:

9 Spironolactone-efficacy 52 of 116 females dropped out of study for various reasons including menstrual irregularities although most patients who completed the regimen also experienced menstrual irregularities (80% of 116) All 64 females who completed the 20 week regimen exhibited clinical improvement 53% excellent 47% good Sato et al. Aesth Plast Surg 2006;30:

10

11 Sato et al. Aesth Plast Surg 2006;30:

12 Side effects

13 Spironolactone side effects Side effects are dose-related: diuresis (29%) menstrual irregularities (22%) breast tenderness (17%) breast enlargement fatigue headache dizziness Pregnancy category C: Concomitant use of COC is recommended to both regulate menses and to prevent pregnancy in many patients Spironolactone is not FDA-approved for the treatment of acne Shaw. J Cut Med Surg 2002;6:541-5.

14 Risks

15 Spironolactone and K+ N=85 (on spironolactone alone or in combination with ocp or antibiotic) mg of spironolactone 73 evaluable subjects Mild, clinically insignificant hyperkalemia ( mEq/L) in 10 (13.7%) Shaw JC. JAAD 2000;43: Spironolactone is not FDA-approved for the treatment of acne

16 Spironolactone and K+ Japanese study of 139 acne patients treated with spironolactone 200mg daily for first 8 weeks After initial 8 weeks, dose tapered by 50 mg every 4 weeks 64 female subjects completed the regimen No significant changes in K+ Sato et al. Aesth Plast Surg 2006;30:

17 Spironolactone and K+ 27 women with acne treated with both a COC containing 30μg of ethinyl estradiol and 3 mg drospirenone and spironolactone 100mg daily Serum K+ was obtained before initiation of therapy and 4-6 weeks after the start of both medications No significant elevation of serum K+ was found in any subject Krunic et al. JAAD 2008;58:60-2.

18 Spironolactone and K+ Retrospective study of 974 healthy young women taking spironolactone for acne vs 1165 healthy young women taking and not taking spironolactone years of age with no cardiovascular disease, renal failure, or use of medications that affect the reninangiotensin-aldosterone system Plovanich M et al. JAMA Dermatology online March 22, 2015.

19 Spironolactone and K+ RESULTS: There were 13 abnormal serum potassium measurements in 1,802 measurements obtained among young women receiving spironolactone therapy for acne (hyperkalemia rate = 0.72%). Baseline rate of hyperkalemia in this population is 0.76%. CONCLUSION: Routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. Plovanich M et al. JAMA Dermatology online March 22, 2015.

20 Spironolactone and K+ Check K+ if: Older age Hx of renal or cardiac disease Hx of impaired hepatic function (minor alterations of fluid and electrolyte balance may precipitate hepatic coma) Higher doses of spironolactone (200mg/day) Spironolactone is not FDA-approved for the treatment of acne

21 Spironolactone and K+ Check K+ if on certain medications: ACE inhibitors Angiotensin II antagonists Aldosterone blockers NSAIDS (i.e. indomethacin) Salt substitutes K+ supplementation Trimethoprim/sulfamethoxazole

22 Sprionolacatone and K+ Trimethoprim decreases urinary K+ excretion by 40% Population-based, nested case-control study of Ontario residents aged 66 or older treated with spironolactone between ,754 treated with spironolactone 17,859 (10%) received at least one prescription for TMP-SMX TMP-SMX was associated with a marked increase in the risk of hospital admission for hyperkalemia Antoniou et al. BMJ 2011;343:d5228.

23 Spironolactone and K+ Conclusion: 60% of all cases of hyperkalemia in older patients taking spironolactone and treated with an antibiotic for UTI could be avoided if TMP-SMX was not prescribed. Antoniou et al. BMJ 2011;343:d5228

24 Spironolactone and K+ Antoniou et al. Trimethoprim-sulfamethoxazole and risk of sudden death among patients taking spironolactone. CMAJ 2015;187(4):e Interpretation: TMP-SMX was associated with an increased risk of sudden death among older patients taking spironolactone. When clinically appropriate, alternative antibiotics should be considered.

25 Hyperkalemiawarning signs Parasthesia Muscle weakness Fatigue Flaccid paralysis of extremities bradycardia

26 Spironolactone and other drugs Lithium Digoxin Diuretics reduce the renal clearance of lithium and should not be used with lithium Spironolactone increased the half life of digoxin and increases the risk of toxicity

27 Spironolactone and breast cancer FDA Black Box Warning: Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Spironolactone should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided. (Dosages used in these rat studies were times higher than those administered to humans; benign adenomas of the thyroid and testes, malignant mammary tumors, proliferative changes in the liver) Kim G and DelRosso J. J Clinical and Aesthetic Derm 2012;5(3): Spironolactone is not FDA-approved for the treatment of acne

28 Spironolactone and breast cancer N=1,475 Prescribed spironolactone for 3-7 years 9 cases of breast cancer vs age-specific rate of 8.3 cases Friedman GD, Ury HK. J Natl Cancer Inst 1980;65: N=461 person-years 3 years of follow-up after exposure to spironolactone No relationship between spironolactone and breast cancer Danielson DAN et al. Am J Epidemiol. 1982;116: Five case-control studies have also found no overall increase in the relative risk for breast cancer associated with spironolactone Kim G and DelRosso J. J Clinical and Aesthetic Derm 2012;5(3): Spironolactone is not FDA-approved for the treatment of acne

29 Spironolactone use and the risk of breast and gynecologic cancers 2.3 million women >20 years of age followed for 28.8 million person-years using a Danish nationwide prescription drug registry 1.3 million spironolactone prescriptions between No evidence of increased risk of breast, uterus or ovarian cancer with spironolactone use. Biggar et al. Cancer Epidemiol. 2013;37(6):870-5.

30 Spironolactone and risk of incident breast cancer in women older than 55 years: retrospective, matched cohort study. 1,290,625 women older than 55 (8.4 million patient years) Exposed cohort included women who received at least 2 prescriptions of spironolactone after 55 years of age 2 unexposed matched controls per case 29,491 new cases of breast cancer were recorded in the study population No difference in breast cancer rates between exposed and nonexposed cohorts (hazard ration 0.99, 95%CI ) Mackenzie et al. BMJ July 13;345:e4447.

31 Spironolactone and pregnancy/nursing Spironolactone is pregnancy category C Spironolactone should NOT be used during pregnancy Increased risk of hypospadias and feminization of the male fetus Spironolactone s active metabolite canrenone has been found in breast milk but at 0.2% of the maternal dose. Both the AAP and the WHO classify spironolactone as compatible with lactation. Murase et al. JAAD 2014;70:401.e1-14. Butler et al. JAAD 2014;70:417.e1-10.

32 Practical approach

33 Spironolactone Dosages 25mg-200mg (I prefer a max dose of 100mg) Side effects: menstrual irregularities breast tenderness/swelling fatigue headaches Higher doses = higher rate of side effects Concomitant use of oral contraceptive lessens menstrual irregularities and prevents pregnancy (risk of feminization of male fetus in late first trimester) Spironolactone is not FDA-approved for the treatment of acne

34 Spironolactone Food increases bioavailability by almost 100% (Package insert)

35 How quickly does it work? No good objective answer Studies are small and frequently spironolactone is used as an adjunct to other topical or oral medications I counsel patients that it may take 3 months to see a meaningful response, similar to other hormonal based therapies

36 How long? Long term unless: Side effects Pregnancy No longer needed Surveys of 91 women followed for 8 years (200 person years exposure to spironolactone; mean treatment length=28.5 months) found no serious illness thought to be attributed to spironolactone Shaw. J Cut Med Surg 2002;6:541-5.

37 Thank you

38

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